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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB | Other Identifier | 2024-A00038-39 |
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The worldwide incidence of hepatobiliary and pancreatic (HPB) cancers is dramatically increasing especially for pancreatic cancer. Increasing age is associated with increased cancer risk. In North America and Europe, most people who are diagnosed with cancer every year are aged 65 years or older. Hepatectomy for hepatocellular carcinoma, intra hepatic and hilar cholangiocarcinoma, gallbladder cancer and hepatic metastases from colorectal cancer allows better survival compared to other treatments. Similarly, pancreaticoduodenectomy (PD) is the standard of care in patients with distal cholangiocarcinoma and patients with resectable pancreatic adenocarcinoma located in the head of the pancreas. This results in an increasing number of elderly patients being evaluated for hepatic and pancreatic surgery. Major hepatectomy and PD are amongst the most invasive and complex procedures in general surgery with high rates of morbidity as well as negative impact on quality of life. Many studies have reported poor post-surgical outcomes in the elderly patients, especially related to co-morbidities that characterizes this population such as, polypharmacy, cognitive decline, depression and malnutrition. The age in elderly cancer patient is not just a number. The management of these patients should not be limited to oncological care, but it should be extended to different clinical domains including physical, cognitive, psychological, socioeconomic and environmental aspects. In this population, the risk of adverse postoperative outcomes is not adequately described by routine format of current preoperative evaluation, such as age, comorbidities and other traditional tests. Furthermore, the Comprehensive Geriatric Assessment (CGA) is scarcely considered. The aim of CGA is to identify current health problems and to guide interventions thus reducing adverse outcomes and optimizing the functional status of older adults. Several trials have indeed shown that CGA and perioperative tailored interventions reduce morbidity and improve patient survival in other surgical disciplines. Similar data is lacking in both hepatic and pancreatic surgery.
The hypothesis is that CGA with perioperative tailored interventions could reduce postoperative morbidity in elderly patients after major hepatectomy and pancreaticoduodenectomy for cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up | |
| Interventional group | Experimental | standard care follow up for the patient: Routine preoperative workup, routine postoperative follow-up with Perioperative geriatric management: CGA, preoperative geriatric consultation, perioperative tailored intervention, postoperative geriatric follow-up |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment | Procedure | CGA:
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complex Index (CCI) value | Comparison of the 90-day postoperative morbidity between patients in the interventional arm (receiving preoperative CGA and perioperative tailored geriatric interventions) and those in the control arm (receiving standard of care). CCI is based on the Clavien-Dindo classification, and takes into account all cumulative complications and receives values between 0 (no complication) and 100 (death). | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life scale: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the EORTC QLQ-C30 | at 3, 6 and 12 months post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella PITTAU, PhD | Contact | +33145596501 | +33 | gabriella.pittau@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella PITTAU, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Clermont-Ferrand | 63000 | France |
there is no plan to make individual participant data (IPD) collected in this study available.
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prospective comparative randomized controlled open label multicentric trial
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| Quality of life scale EQ-5D-5L |
Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the EQ-5D-5L |
| at 3, 6 and 12 months post surgery |
| Quality of life scale ELD14 | Quality of life will be measured at the enrolment visit (baseline) and at 3, 6 and 12 months after surgery (M3, M6 and M12), using the ELD14. | at 3, 6 and 12 months post surgery |
| Discharge status | Discharge status at 3 months after surgery (M3): home, rehabilitation facility, and still hospitalized or deceased | 90 days after surgery |
| All-cause mortality at 90 days after surgery | 90-day postoperative mortality | at 3 months post surgery |
| complication occurence and classification | Occurrence of all complications classified as grade II, III, IV, according to Clavien-Dindo scale within 90 days after surgery | at 3 months post surgery |
| Post-operative hospital length of stay (in days) | Post-operative hospital length of stay (in days) defined as the time from surgery to the post-operative discharge date, transfer to a subacute service or death whichever comes first. | through study completion (an average of 5.5 years) |
| Post-operative ICU length of stay (in days) | Post-operative ICU length stay (in days) defined as the time from the postoperative ICU entry date to ICU discharge date or death whichever comes first. | through study completion (an average of 5.5 years) |
| Loss of independence at 3 months after surgery | Loss of independence at 3 months after surgery (M3) defined by a score lower than 6/6 in ADL | 90 days after surgery |
| Time (in days) between the date of randomization and the date of surgery | To compare between arms (interventional vs control arms) the delay between randomization and surgery | from randomization to surgery, a maximum of 1 month |
| Overall survival | Overall survival defined as the time from surgery to death from any cause over 1 year follow-up | at 12 months post surgery |
| time from surgery to cancer recurrence or death from any cause | Disease-free survival defined as the time from surgery to cancer recurrence or death from any cause over 1 year follow-up | through study completion (an average of 5.5 years) |
| Percentage of patients that completed the geriatric intervention | To estimate, within the interventional arm the proportion of patients who underwent the complete geriatric intervention | through study completion (an average of 5.5 years) |
| Percentage of patients contraindicated to surgery after CGA | To estimate, within the interventional arm the proportion of patients definitively contraindicated to surgery after CGA because too frail | through study completion (an average of 5.5 years) |
| Time (in days) between the dates of randomization and preoperative geriatric consultation | To estimate, within the interventional arm the delay between randomization and preoperative geriatric consultation | through study completion (an average of 5.5 years) |
| Time (in days) between the dates of preoperative geriatric consultation and onset of tailored interventions | To estimate, within the interventional arm the delay between preoperative geriatric consultation and tailored interventions | through study completion (an average of 5.5 years) |
| Time (in days) between the dates of preoperative geriatric consultation and surgery | To estimate, within the interventional arm the delay between preoperative geriatric consultation and surgery | through study completion (an average of 5.5 years) |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
|
| Chru Lille - Hopital Huriez | Lille | 59000 | France |
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| Hôpital Croix Rousse, HCL | Lyon | 69000 | France |
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| Hôpital Edouard Herriot, HCL | Lyon | 69000 | France |
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| Hôpital La Timone | Marseille | 13000 | France |
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| Hôpital Cochin | Paris | 75014 | France |
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| Institut Mutualiste Montsouris | Paris | 75014 | France |
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| CHU ROUEN - Site Charles Nicolle | Rouen | 76000 | France |
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| Hôpital Rangueil | Toulouse | 31000 | France |
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| Hôpital Paul-Brousse | Villejuif | 94800 | France |
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| Institut Gustave Roussy | Villejuif | 94800 | France |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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